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Peptide-Based Immunization for Colon- and Pancreas-Carcinoma (PiCoP-GLOBAL)

PiCoP-GLOBAL is an international multicenter epidemiological observational study with the goal to develop diagnostic tools for personalized, immune-based therapies in colon and pancreatic tumors.

This study is closely connected to the national PiCoP study in Germany and a follow-up vaccination study.

  1. Peptide-Based Immunization for Colon- and Pancreas-Carcinoma (PiCoP-GLOBAL)

Summary and Rationale

Overview

The Peptide-based Immunization for Colon- and Pancreas-Carcinoma Study (PiCoP-GLOBAL) is a global observational study focusing on the identification of tumor-specific neoantigens as the basis for developing a personalized, immune-based therapy to target the patient’s own immune response against the tumor.


Study access on CentoPortal® for participating physicians

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Study Rationale

Standard of care treatment for colon and pancreas cancer is stage dependent and includes surgical, chemotherapeutic, and radiation therapy. However, since the prognosis of advanced colon cancer and pancreas tumors, in general, is very poor, there is an urgent need for improved treatment.

The enhancement of the immune response via vaccination is among new therapeutic options by using either cell-specific antigens, over-expressed tumor-specific antigens, or mutated tumor-specific antigens (neoepitopes). The biggest potential for high specificity but presuppose an extensive characterization of the respective tumor lies with mutated tumor-specific antigens. In order to identify a neoepitope-based vaccination approach for patient-individualized treatment options, the molecular characteristics of tumors have to first be analyzed.

  • Study participants will have access to medical reports with somatic mutations related to the cancer diagnosis via their physicians
  • In case neo-antigens that are suitable for the production of patient individual vaccines are found, enrollment in the follow up clinical study is possible

All patients participating in PiCoP-GLOBAL will be making an important contribution to the understanding of colon and pancreatic tumors, and to the potential development of individualized treatment options.

Information about the Study

Design: International epidemiological observational non-interventional study

Study population: Patients with pancreas or colorectal carcinoma undergoing surgery

Number of patients: 100 participants

First patient in: April 2019

Last patient in: June 2021

Inclusion period: 24 months

Objectives:

  • Identification of tumor-specific mutations on the genomic level.
  • Validation of tumor-specific mutations on transcriptional and/or translational level.
  • Development of a personalized vaccination strategy.
  • Development of follow-up diagnostic strategies.
  • Biomarker establishment in patients with pancreas or colon carcinoma.

Aim: Development of individualized treatment options for colon and pancreas tumors.

ClinicalTrials.gov

Study Design

Participants fulfilling the inclusion criteria will be enrolled in the study after providing informed consent. At the time of standard-of-care surgery to remove the tumor, all participants will have a research blood sample drawn. From the tissue removed during surgical treatment, a tumor sample and a control tissue sample will be obtained for the study.

Additional blood samples may be taken at different time points.

All materials are sent to CENTOGENE and analyzed in CENTOGENE’s laboratory in Germany.

The samples will be tested genetically for tumor-associated mutations and MS/MS-based for neoepitopes and for biomarker studies. The collected data will be used in a multi-omics approach to predict neoepitopes.

Follow-up blood samples will be tested genetically and through specific immune monitoring to verify a pre-existing immune response against neoantigens in non-vaccinated patients, to monitor the patients’ immune response during chemotherapy and to monitor the patients’ response to treatment.

Any patients in which promising neoantigens for vaccine production are found may be offered participation in a future clinical study.

Diseases Facts

Colorectal Carcinoma Facts*

  • Colorectal cancer is the fourth most common cause of death from cancer worldwide: an estimated 694,000 deaths annually
  • Colorectal cancers encompass tumors that occur in both the colon and the rectum
  • One of the most common cancer types worldwide: 10% of the global cancer incident burden in 2012
  • Third most common cancer in men (an estimated 746,000 new cases per year)
  • Second most common in women (an estimated 614,000 new cases per year)

Pancreas Carcinoma Facts*

  • Because of its poor prognosis, pancreatic cancer is the seventh most common cause of death from cancer worldwide
  • Estimated to be the 12th most common cancer in men (178,000 cases) and the 11th most common in women (160,000 cases) worldwide in 2012
  • 68% of the new cases occurred in countries at high or very high levels of human economic development
  • Estimated 330,000 deaths from pancreatic cancer in 2012

*Source: WHO 2014 World Cancer Report estimates

Cooperation Partners

CENTOGENE is collaborating for that project with biotech companies, the University of Rostock and the University of Greifswald in the PiCoP study, made possible through co-funding from the European Regional Development Fund (ERDF). In addition to recruiting patients, both universities contribute through scientific projects for PI3K/ATK/mTOR Pathway studies, establishing of cell lines or transplant models, immune monitoring, and epigenetic profiling in colon cancer tissue.

CENTOGENE is also collaborating with international partners for the PiCoP Global Study – with the first international site included in the study in April 2019 with partners in Pakistan (all members of the Surgical Oncology Society Pakistan).

Inclusion Criteria
Informed consent is obtained from the participant
Patients with pancreas or colorectal carcinoma undergoing surgery
The participant is older than 18 years old

Contact

For more information please contact:

Prof. Dr. Peter Bauer, Project Lead
CENTOGENE AG
Am Strande 7
18055 Rostock
Germany
Email: peter.bauer(at)centogene(dot)com

Dr. Susann Krake, Project Manager
CENTOGENE AG
Am Strande 7
18055 Rostock
Germany
Email: susann.krake(at)centogene(dot)com

Dr. Volha Skrahina, Team Leader Clinical Studies
CENTOGENE AG
Am Strande 7
18055 Rostock
Germany
Email: volha.skrahina(at)centogene(dot)com

Study access on CentoPortal® for participating physicians

CentoPortal®